Pharmaceutical supply chains are particularly complex, requiring the input of multiple stakeholders with many important requirements placed upon them, which brings many challenges. Pharma Supply Chain with Blockchain offers a digital ledger system to securely record transactions on a peer to peer network in chronologically ordered and transparent blocks.
Naturally, having so many stakeholders able to input and change data adds complexity to the quality of the data. It is difficult to monitor and validate the correct information and secure against human error and missing documentation. Interactions are often time-sensitive, yet documentation may not always be managed quickly. There is also the overall issue of manufacturers, logistics companies, wholesalers and pharmacists not being able to have complete visibility on the authenticity of a drug and the quality while it is in transit.
Blockchain offers a digital ledger system to securely record transactions on a peer to peer network in chronologically ordered and transparent blocks.
Currently, the medicine verification system and the supply chain must meet the following criteria:
• Updating and Sharing data:
- Allow multiple parties to update and share data
- Verification ensures that the information can be trusted
- Interaction with national and European medicines verification system to allow all parties to have visibility in the drug authenticity.
There are significant issues within the current system however:
• Intermediaries add complexity:
- The more parties involved in handling the medication, the higher the risk of interception or damage
• Interactions are time sensitive:
- Drugs must be delivered within a good timeframe as pharmacists need to be able to provide a quick service to patients
- Manufacturers, logistic companies, wholesale and pharmacies may not be able to offer complete visibility on the authenticity of the drug whilst ensuring quality has remained intact.
Using a blockchain solution has advantages
Pharma Supply Chain with Blockchain can make a substantive difference to the pharmaceutical industry. At every stage of the process, barcodes would be scanned and recorded onto a blockchain ledger system which, in turn, records and creates an audit trail of the drug journey. Sensors can also be incorporated into the supply chain, with temperature or humidity being recorded onto the ledger system. This is particularly important for drugs requiring fridge storage, such as insulin or expensive specially manufactured medicines.
When the drug reaches the pharmacy, the pharmacist can tell through the blockchain audit trail, if the drug has been compromised at any point of the journey. Even atthe time of dispensing the prescription, biometric measures can be used to record the dispenser and pharmacist checking the prescription. This can all be recorded onto the ledger, allowing drugs to be tracked from the moment of creation to the moment the patient takes the drug home.
• Reduced complexity and costs:
– Pharma Supply Chain with Blockchain becomes traceable and drugs are easier to track
– Information systems will hold expiry date details which improves stock control and rotation
• Reduces errors:
– Drugs can be verified and authenticity can be ensured
– Patient harm is reduced as drug checks are improved
• Enhances security:
– Counterfeit drugs are minimised
– Patient harm is reduced
– Data is kept safe
• Proven resilience:
– The system’s data will remain protected
• Shared, trusted transactions:
– All parties are able to access the drug information when needed to ensure the quality of the drug being dispensed
– Parties must be able to trust the data as it determines if a drug can be dispensed
• Creates an audit trail:
– Drugs are easily traced making recalls easier
– Parties can see if the process has become compromised at any point
• Enhances transparency between authorised parties:
– All parties can see every stage of the drug journey to ensure the drug authenticity
– Regulators, such as pharmacy inspectors, can monitor the rate of counterfeit drugs entering the supply chain, with more accuracy
In Europe, the new regulation on serialization was made applicable on the 9th of February 2019. The objective of this system is to enable the identification and authentication of medicines guaranteed by an end-to-end verification of the supply chain of all medication.
However, in Europe, with the new Falsified Medicines Regulation (FMD), pharmaceutical companies will have to send the serial numbers of each medicine to a European hub. Then, these will be sent to the national databases of each country in which the drug is marketed. The hub is therefore the guarantee for the interoperability between all these databases and is a central authority, moving thus away from the principle of decentralization provided by the blockchain.
Through the use of blockchain, the drug journey can become more secure and streamlined. Every delivery can be tracked, with the delivery driver traced through biometric measures. Every checkpoint involving the drug is recorded and traced via biometric measures, 2D barcode scans or sensor technology. As the drug is tracked from creation to patient, the whole of the drug journey becomes seamless, accurate, audited and secure.